ObsEva SA (OBSV)

[Frankestin]

The NDA submission is a major milestone in making linzagolix available in the U.S., and an important step toward addressing the diverse medical needs that exist for women with uterine fibroids,” said Brian O’Callaghan, CEO of ObsEva. “Our positive Phase 3 PRIMROSE results underscore linzagolix’s clinical utility and well-known differentiated profile. If approved, linzagolix will be the first oral GnRH antagonist to offer treatment options for women who cannot or do not want to take hormones, as well as for women who are able to take additional hormone therapy. We look forward to overcoming existing challenges in the treatment of uterine fibroids -- with linzagolix’s unique low-dose option (100 mg without ABT) and high dose option (200 mg with ABT) -- and will work with the FDA through the regulatory process as we prepare for commercialization.”

Concurrently, ObsEva is also working closely with the European Medicine Agency’s (EMA) to achieve marketing approval. Linzagolix previously received validation of the marketing authorization application (MAA) with an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) expected in Q4 2021.